Gamma Enterprises, Inc. - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gamma Enterprises, Inc. Chemistry ✕
22 devices
Cleared
May 15, 1979
GAMMA SMAC REAGENTS
Chemistry
49d
Cleared
May 03, 1978
CREATINE PHOSPHOKINASE (CPK)
Chemistry
34d
Cleared
May 03, 1978
SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE
Chemistry
34d
Cleared
May 03, 1978
CARBON DIOXIDE REAGENTS
Chemistry
34d
Cleared
May 03, 1978
SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
Chemistry
34d
Cleared
Nov 22, 1977
CHLORIDE
Chemistry
62d
Cleared
Nov 22, 1977
LACTATE DEHYDROGENASE
Chemistry
62d
Cleared
Nov 22, 1977
WETTING AGENTS
Chemistry
62d
Cleared
Nov 03, 1977
CREATININE
Chemistry
43d
Cleared
Nov 03, 1977
SERUM IRON
Chemistry
43d
Cleared
Nov 02, 1977
ALKALINE PHOSPHATASE
Chemistry
42d
Cleared
Nov 02, 1977
INORGANIC PHOSPHORUS
Chemistry
42d